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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during functional testing, the device's screen turned completely white and was illegible.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was received at zoll medical corporation.The customer's report was verified and attributed to a faulty lcd display module.The lcd module was replaced to remedy the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
X SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key10326304
Report Number1220908-2020-02211
Device Sequence Number3462700
Product Code MKJ
UDI-Device Identifier00847946019372
UDI-Public00847946019372
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K112432/P160
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/06/2020
Supplement Date Received by Manufacturer07/06/2020
Initial Report FDA Received Date07/27/2020
Supplement Report FDA Received Date08/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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